American College of Cardiology
American College of Cardiology
May 02, 2016
4 min watch

VIDEO: LAA occlusion device safe, effective in regulatory study

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CHICAGO — At the American College of Cardiology Scientific Session, David R. Holmes Jr., MD, of Mayo Clinic, discusses real-world findings related to a left atrial appendage occlusion device (Watchman, Boston Scientific) in patients with nonvalvular atrial fibrillation at increased risk for stroke.

Holmes, a member of the Cardiology Today Editorial Board, and colleagues presented findings from a cohort of 1,683 patients treated with the device in the United States after FDA approval but before a decision about whether to establish a CMS registry.

The patients were treated by interventional cardiologists or electrophysiologists under the supervision of Boston Scientific personnel and according to the instructions for use agreed to by the FDA and the manufacturer.

Holmes said the rate of procedural success was 95%, better than that seen in the PROTECT AF randomized controlled trial but similar to the rate in subsequent randomized trials and registries; the seal success rate was also 95%; and the average procedure time was approximately 1 hour.

“This would be a group of patients that will have received protection from stroke in the setting of nonvalvular [AF] having had a successful procedure performed,” Holmes said.